510(k) K132889

FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR SET (4 MM) by Nucletron B.V. — Product Code JAQ

K132889 is an FDA 510(k) premarket notification submitted by Nucletron B.V. for the device "FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR SET (4 MM)". The FDA issued a decision of Substantially Equivalent on February 26, 2014. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Nucletron B.V. has at least 10 other 510(k) clearances on record.